The present invention relates to a sterilizing method for a blood processing device such as an artificial kidney or the like.
As the blood processing device, there have been artificial kidney, liver, lungs, curing abdominal dropsy processing device, or plasma separator, which serve as substitutions for the organs of the human body. Each of them circulates the blood externally of the human body and removes waste materials in the blood by utilizing a combination of filtrating, dialyzing, absorbing and other processes, or utilizing anyone of them individually.
For these devices, a membrane module or a hemoperfusion cartridge are frequently employed. The former is made by assembling membranes of hollow fibers of from about several hundred to about 10,000 of a cellulose such as cuprammonium rayon or viscose rayon, or a synthetic polymer such as polyvinylalcohol, polymethacryrate, polypropylene or polyacrylonitrile. The latter is made of petroleum-based activated charcoal or plum husk-based activated charcoal.
Said membrane or hemoperfusion cartridge are dealt with by an ethylene oxide gas sterilizing method, a gamma radiation sterilizing method, a formaline sterilizing method, or a steam sterilizing method. However, since the two former methods carry out the sterilization under the dried condition, they will perhaps reduce functions of the membrane. Especially, with respect to the hollow fiber membrane, in case of the dried condition, the blood runs unsmoothly within the hollow fibers, so that air bubbles are removed. Further in the ethylene oxide gas sterilization, residual toxicity after the sterilization is problem. The gamma radiation sterilization modifies or dissolves the membrane, the casing or other parts, and consequently the dissolved substances will elute into the blood. In the formalin sterilization, the formalin per se is harmful to the human body. Therefore, the device should be washed away for a long period of time.
In these circumstances, recently a steam autoclave sterilizing method has been much used. This method has been employed not only in the blood processing device but also in indwelling catherters and the blood circulating line or tube which communicates a patient with the blood processing device. However, in this sterilizing method, the blood processing device and the blood circulating line are sterilized individually, and they should be connected for use. If the blood processing device of the wet condition is used at connection, the liquid leaks from an inlet or an outlet of the device and the device is polluted, and the air will go thereinto.
Since the blood line should be soft and transparent, frequently used is a PVC resin forming agent containing plasticizer such as dioctyl phthalate. However, if the resin which contains the plasticizer contacts an electrolyte such as a physiological saline solution, the plasticizer enters, though only slightly, the electrolyte. If the sterilization is carried out under the condition of filling the physiologocal saline solution, the filled solution is discharged before use of the circulating line, and it is necessary to wash the line with a new physiological saline solution and take out the air from the line. This is known as a priming.
The priming is undertaken, as shown in FIG. 1, by connecting an inlet circulating line 17 and an outlet circulating line 18 to the blood processor 15, connecting a priming set 6 having a clamp 4, a drip chamber 3 and others to a priming line 7 which branches from the main tube of the inlet line 17, piercing an introducing needle 2 at an end point of the priming set 6 into a mouth of a bottle 1 supporting the physiological saline solution, and running the solution within the bottle into the inlet line 17, the outlet line 18 and the blood processor 15.
However, in such conventional methods, it is necessary to take trouble of disinfecting a needle piercing portion of a rubber plug in the bottle mouth, when the connector 5 is stiffly mounted at the end of the priming line 7 or the needle 2 is pierced into the mouth of the bottle. In addition, if the introducing needle is plastic, large force is required. Further, it is necessary to clamp luer connectors 32 by means of many forceps for preventing leakage of the physiological saline solution. The prior art is troublesome in preparation requiring much processes and therefore it is unhygienic.
In addition, when the priming is opened, the waste liquid is discharged from the outlet 24 of the outlet line 18, and at this time the outlet 24 is held with an adhesive tape to an edge of a vessel such as a bucket. This manner makes the outlet 24 touch the vessel, or directly exposes it in the air. This is unsanitary. Further, it is troublesome to support the outlet 24 to the vessel with the adhesive tape.
The present invention has been devised to remove disadvantages involved in the prior art.
An object of the invention is to enable to carry out the steam autoclave sterilization under condition of communicating all of the processing device, the inlet line, the outlet line and others, whereby the connecting operation during use is no longer necessary, so that the cost for the sterilization is lowered.
Another object of the invention is to provide a blood processing device where preparation for the priming is performed easily and hygienically.
A further object of the invention is to deal with the waste solution in an easy and hygienic manner.
Another object of the invention is to provide a blood processing device which is convenient to an urgent case or home dialysis which has been recently popular.
Other objects will be apparent from explanation of the invention in reference to the attached drawing and the appended claims.